藥物警訊（藥師週刊 第1732期）

Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Letter to Healthcare Professionals - Clogged, Blocked Oral Syringes and Feeding Tubes

AUDIENCE: Risk Manager, Pharmacy, Home Care

The FDA has received reports that Teva's lansoprazole delayed-release orally disintegrating tablet has clogged and blocked oral syringes and feeding tubes, including both gastric and jejunostomy types, when the drug is administered as a suspension through these devices. The tablets may not fully disintegrate when water is added to them and/or they may disintegrate but later form clumps. These clumps can adhere to the inside walls of oral syringes and feeding tubes. In some cases, patients have had to seek emergency medical assistance and their feeding tubes have had to be unclogged or removed and replaced.

BACKGROUND: Lansoprazole is a proton pump inhibitor (PPI) medication. It is approved for the treatment of gastric and duodenal ulcers, gastroesophageal reflux disease (GERD), erosive esophagitis (EE), and Zollinger-Ellison Syndrome (a condition involving overproduction of stomach acid).

Teva Pharmaceuticals has voluntarily withdrawn its lansoprazole delayed-release ODT product from distribution at this time. However, some product may remain in stock in pharmacies and other facilities, and some patients may still have the product in their possession. The product may also be sold under the following labels: Sharp Corporation, Cardinal Health, and Quality Packaging Specialist, Inc.

RECOMMENDATIONS:

* FDA recommends that healthcare professionals evaluate their medication stock and not dispense the Teva lansoprazole delayed-release ODT product to patients for whom the product will be administered through an oral syringe or feeding tube.

* Patients and caregivers should be instructed not to administer the Teva lansoprazole delayed-release ODT product through oral syringes and/or feeding tubes due to the potential for clogging and blockage of the oral syringe or tube.

* Read the Healthcare Professional Letter for other specific recommendations and for National Drug Code (NDC) numbers for the affected Teva products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Letter to Healthcare Professionals, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

FDA接獲回報說，Teva製藥公司出產的lansoprazole延遲釋放口溶錠劑在溶解成懸浮液給藥時，會堵塞餵藥針筒、鼻胃管及 jejunostomy餵養管。可能是因為加水後藥品沒完全溶解或溶解完後又結成塊狀，這些塊狀物會吸附在針筒及管子的內壁上，有些案例中的病人還尋求緊 急醫療幫助來清除堵塞物或更換管子。

Lansoprazole是一種氫離子幫浦阻斷劑（proton pump inhibitor, PPI），可治療腸胃道潰瘍、胃食道逆流、糜爛性食道炎及Zollinger-Ellison Syndrome（是一種胃酸過度製造的情形）。Teva公司已經自主性下架此藥品，但是有些產品可能還在藥局、其他場所及病人家中，而這些產品可能是 Sharp Corporation、Cardinal Health及Quality Packaging Specialist公司銷售。

建議

* FDA建議醫療人員檢視藥品，且不要調劑此產品給須經針筒或管子餵藥的病人。
* 因為此產品可能堵塞針筒或管子，病人或照護者應遵從指示，不要經由針筒或管子給藥。
* 閱讀Healthcare Professional Letter上的其他特殊建議，及產品的National Drug Code (NDC)。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251575.htm

[Posted 04/15/2011]

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部